VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM— 510(k) K992406
Substantially EquivalentMitek Products
FDA 510(k) clearance K992406 for VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM, Substantially Equivalent on 1999-08-06. Applicant: Mitek Products. Device class: 2.
Clearance details
- Applicant
- Mitek Products
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Westwood, MA, US
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More clearances from Mitek Products
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.